Trials / Completed
CompletedNCT00545103
Prevention of Recurrence of Diverticulitis
A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 592 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPD476, MMX™ mesalazine, 1.2g extended release tablet | SPD476 1.2g administered Once Daily (QD) |
| DRUG | SPD476, MMX™ mesalazine, 2.4g extended release tablet | SPD476 2.4g administered Once Daily (QD) |
| DRUG | SPD476, MMX™ mesalazine, 4.8g extended release tablet | SPD476 4.8g administered Once Daily (QD) |
| DRUG | Placebo | Placebo administered Once Daily (QD) |
Timeline
- Start date
- 2007-12-06
- Primary completion
- 2011-11-28
- Completion
- 2011-11-28
- First posted
- 2007-10-17
- Last updated
- 2021-06-11
- Results posted
- 2012-12-19
Locations
131 sites across 10 countries: United States, Brazil, Canada, Finland, Germany, Hungary, Italy, Netherlands, Romania, South Africa
Source: ClinicalTrials.gov record NCT00545103. Inclusion in this directory is not an endorsement.